Urethral apparatus with position indicator and methods of use thereof

ABSTRACT

An apparatus and method for placement of a tubular body in the urethra. The tubular body includes a proximal portion adapted for placement toward a bladder end and bladder neck end of the urethra and a distal portion opposite from the proximal portion. A sensor component located on the tubular body is responsive to a feature of the urethra and outputs a first signal indicating proper placement of the proximal portion of the tubular body relative to the bladder and bladder neck. Preferably, an insertion tool is used during positioning of the urethral apparatus. The insertion tool is coupled to the distal end of the urethral apparatus and is used to push the urethral apparatus proximally in the urethra. The first signal can be transmitted from the urethral apparatus through the insertion tool from which it is perceivable by the person positioning the urethral device. Upon proper placement, the insertion tool is decoupled from the urethral apparatus and withdrawn leaving the urethral apparatus in place in the urethra with the proximal portion properly positioned relative to the bladder neck and bladder.

REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. provisional applicationSer. No. 60/036,944, filed Feb. 7, 1997, the entire disclosure of whichis incorporated herein by reference, U.S. application Ser. No.08/914,487 filed Aug. 19, 1997, now abandoned, the entire disclosure ofwhich is incorporated herein by reference, and the U.S. patentapplication entitled "URETHRAL APPARATUS WITH HIGH FLOW VALVE ANDMETHODS OF USE THEREOF" filed on even date herewith, Attorney Docket No.8889-9, the entire disclosure of which is incorporated herein byreference.

FIELD OF THE INVENTION

The present invention relates generally to apparatuses for placement inthe urethra and methods of using such apparatuses, and more particularlyto apparatuses that can be positioned in the urethra for short-term orlong-term use and that provide functions such as valving for flowcontrol or that provide introduction passageways for the placement ofdiagnostic or therapeutic equipment into the urinary tract.

BACKGROUND OF THE INVENTION

Urine flow problems include urine retention, incontinence, and difficulturination. These problems, especially retention and ischuria, can haveserious consequences. Retention can result from any of a number ofcauses, including without limitation, spinal cord injury or tumors,coma, typhoid, peritonitis, prostatic enlargement, urethral stricture,urethritis, cystitis, bladder tumors, urethral calculus, Parkinson'sdisease, prostatitis, or multiple sclerosis. Patients suffering fromthese and other conditions often require some interventional means toperiodically drain the bladder. Failure to do so can result in damage ofthe epithelium and detrusor muscles associated with the bladder, and anincreased potential for bacterial invasion and urinary tract infection.

The urine flow problem of incontinence is the inability to retain urine.Incontinence can result from paralysis or relaxation of the sphinctersor contraction of the longitudinal muscular layers of the bladder.Incontinence can also occur in coma, epileptic seizure, spinal cordinjury or tumors associated with the spinal cord, spinal meningitis, orlocal irritation of the bladder. Incontinence may be categorized aseither stress incontinence, in which urine is expelled during stressessuch as exercise, coughing, and laughing; urge incontinence, in whichthe patient in unable to control the urge to urinate in part due touninhibited bladder contractions; or mixed incontinence, in which thepatient experiences both stress and urge incontinence.

Difficult urination or dysuria can result from urethral strictures,enlarged prostates, atony and impairment of the bladder's muscularpower, and inflammatory conditions involving the urethra, bladder, orlower ureter.

Devices have been developed to be positioned in the urethra and/orbladder to correct the problems of urine flow. These devices, includingurinary drainage catheters, have been used for many years. A device ofthis type requires proper placement in the urethra in order to operatecorrectly and with minimal discomfort. It can be difficult to properlyposition a urine-control device in the urethra. Some of these urethraldevices require that a physician use a cystoscope or rely on ultrasound,fluoroscopy, X-ray, or similar technology for position information toproperly place a device in the urethra. These techniques requirerelatively expensive equipment. Another way that it can be determinedthat a urethral device has been positioned into the bladder is toobserve the flow of urine through the device which is an indication thatthe bladder has been entered. This method requires that a through-lumenor valve can be maintained in an open position during insertion and thatthe bladder be sufficiently full so that a flow of fluid is readilyobservable. Therefore, this method may not be available if the patient'sbladder is empty. Accordingly, devices for placement in the urethra arerelatively hard to properly position and have often required that askilled physician position the device using expensive equipment.

Accordingly, it is an object to provide a urethral device that can bepositioned relatively easily.

SUMMARY OF THE INVENTION

To address the above concerns, the present invention provides anapparatus and method for placement of a tubular body in the urethra. Thetubular body includes a proximal portion adapted for placement in theurethra toward a bladder and bladder neck and a distal portion oppositefrom the proximal portion. A sensor component located on the tubularbody is responsive to a feature of the urethra and outputs a firstsignal indicating proper placement of the proximal portion of thetubular body relative to the bladder and bladder neck. Preferably, aninsertion tool is used during positioning of the urethral apparatus. Theinsertion tool is coupled to the distal end of the urethral apparatusand is used to push the urethral apparatus proximally in the urethra.The first signal can be transmitted from the urethral apparatus throughthe insertion tool from which it is perceivable by the personpositioning the urethral device. Upon proper placement, the insertiontool is decoupled from the urethral apparatus and withdrawn leaving theurethral apparatus in place in the urethra with the proximal portionproperly positioned relative to the bladder neck and bladder.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, in which like reference numerals indicate correspondingparts through the several views;

FIG. 1 shows a side view of a first embodiment of a urethral apparatusand an insertion tool showing the insertion tool partially cutaway.

FIG. 2 is a side sectional view of a distal portion and sensingcomponent of the urethral apparatus of FIG. 1 and a partially cutawayview of a proximal portion of the insertion tool, uncoupled from theurethral apparatus.

FIG. 3 is an end view of the insertion tool of FIG. 2 taken from line3-3'.

FIG. 4A is a side view of the deformable coupling of FIG. 3 in areleased position.

FIG. 4B is an end view of the deformable coupling of FIG. 4A.

FIG. 4C is a side view of the deformable coupling of FIG. 4A in a lockedposition.

FIG. 5A is a side sectional view of the urethral apparatus of FIG. 1 anda partially cutaway view of a proximal portion of the insertion tool,coupled to the urethral apparatus.

FIG. 5B is a sectional view of the urethral apparatus taken along line5B-5B' of FIG. 5A.

FIG. 5C is a sectional view of the urethral apparatus taken along line5C-5C' of FIG. 5A.

FIG. 6A is an end view of the apparatus first contact collar of FIG. 5A.

FIG. 6B is a sectional side view of the apparatus first contact collarof FIG. 5A.

FIG. 7 is a side view of the proximal segment of the coupled urethralapparatus and insertion tool of FIG. 1 in one stage of being positionedin a urethra.

FIG. 8 is a close-up view of a distal end of the sensing component ofthe urethral apparatus during the stage of positioning shown in FIG. 7.

FIG. 9 is a side view of the coupled urethral apparatus and insertiontool of FIG. 7 in another stage of being positioned in the urethra.

FIG. 10 is a close-up view of a distal end of the sensing component ofthe urethral apparatus during the stage of positioning shown in FIG. 9.

FIG. 11 is a side view of the urethral apparatus of FIG. 1 coupled to analternate embodiment of an insertion tool.

FIG. 12 is a side view partially in section of the insertion tool ofFIG. 11.

FIG. 13 is an exploded view of components of the insertion tool shown inFIG. 12.

FIG. 14 is a side view of the removable cover with the stop component ofthe insertion tool shown in FIGS. 11-13.

FIG. 15 is a side sectional view of the urethral apparatus of FIG. 1 anda partially cutaway view of a proximal portion of the insertion tool ofFIGS. 11-14, coupled to the urethral apparatus.

FIG. 16A is a schematic flow diagram illustrating the electrical flowduring coupling of the insertion tool and urethral apparatus of FIG. 15.

FIG. 16B is a schematic flow diagram illustrating the electrical flowduring positioning of the insertion tool and urethral apparatus of FIG.15.

FIG. 17 is a sectional view of another embodiment of a urethralapparatus having a preformed portion.

FIG. 18 is a sectional view of still another embodiment of a urethralapparatus, utilizing a piezoelectric transducer or membrane switch.

FIG. 19A is a schematic flow diagram illustrating the electrical flowduring coupling of the insertion tool and urethral apparatus of FIG. 18.

FIG. 19B is a schematic flow diagram illustrating the electrical flowduring positioning of the insertion tool and urethral apparatus of FIG.18.

FIG. 20 is a sectional view of an alternate embodiment of a urethralapparatus, utilizing acoustic sensing.

FIG. 21A is a schematic flow diagram illustrating the electrical flowduring coupling of the insertion tool and urethral apparatus of FIG. 20.

FIG. 21B is a schematic flow diagram illustrating the electrical flowduring positioning of the insertion tool and urethral apparatus of FIG.20.

FIG. 22A is a side view of the proximal end of an embodiment of theinsertion tool illustrating the contact collar assembly and itsinterface with the contact collar of the urethral apparatus.

FIG. 22B is an end view of the contact collar housing of FIG. 22A.

FIG. 22C is an end view of the contact collar of FIG. 22A.

FIG. 22D is an end view of the contact collar housing of the urethralapparatus of FIG. 22A.

FIG. 23 is a sectional view of another alternate embodiment of aurethral apparatus that utilizes acoustic sensing.

FIG. 24 is a sectional view of a first alternate embodiment of aurethral apparatus that utilizes fluid flow sensing.

FIG. 25A is a partially cutaway side view of an insertion tool to beused with the embodiment of FIG. 24.

FIG. 25B is a close-up view of the proximal portion of the insertiontool of FIG. 25A.

FIG. 26A is a schematic flow diagram illustrating the electrical flowduring coupling of the insertion tool and urethral apparatus of FIG. 24.

FIG. 26B is a schematic flow diagram illustrating the electrical flowduring positioning of the insertion tool and urethral apparatus of FIG.24.

FIG. 27 is a sectional view of a second alternate embodiment of aurethral apparatus that utilizes fluid flow sensing.

FIG. 28 is a sectional view of a third alternate embodiment of aurethral apparatus that utilizes fluid flow sensing.

FIG. 29A is a cross-sectional view taken along line 29A-29A' of FIG. 28showing the volume-deformable member in an expanded configuration.

FIG. 29B is the same cross-sectional view as shown in FIG. 29A showingthe volume deformable member in a depressed configuration.

FIG. 30A is a sectional view of a fourth alternate embodiment of aurethral apparatus that utilizes fluid flow sensing shown in a closedmode.

FIG. 30B is a sectional view of the embodiment of the urethral apparatusshown in FIG. 30A shown in an open mode.

FIG. 31 is an expanded cross sectional view of the fluid passages shownin FIG. 30, taken along lines 31-31'.

FIG. 32 is a close-up sectional view of the proximal portion of thefluid passageways shown in FIGS. 30 and 31.

FIG. 33A is a partially cutaway side view of an insertion tool for usewith the embodiment of the urethral apparatus in FIG. 32 FIG. 33B is aclose-up view of the proximal portion of the insertion tool of FIG. 33A.

FIG. 34 is a sectional view of an alternate embodiment of a urethralapparatus that uses electrical resistance measurement for positionsensing.

FIG. 35A is a schematic flow diagram illustrating the electrical flowduring coupling of the insertion tool and urethral apparatus of FIG. 34.

FIG. 35B is a schematic flow diagram illustrating the electrical flowduring positioning of the insertion tool and urethral apparatus of FIG.34.

FIG. 36 is a sectional view of an alternate embodiment of a urethralapparatus that uses thermoelectric cooling to provide for positionfeedback

FIG. 37 is an expanded side view of the semiconductor used in thesensing component of FIG. 36.

FIG. 38A is a schematic flow diagram illustrating the electrical flowduring coupling of the insertion tool and urethral apparatus of FIG. 36.

FIG. 38B is a schematic flow diagram illustrating the electrical flowduring positioning of the insertion tool and urethral apparatus of FIG.36.

FIG. 39 is an expanded partial top view of an alternate embodiment of aurethral apparatus that uses fiber optics to provide for positionfeedback

FIG. 40 is a side view of the urethral apparatus of FIG. 39 at one stageof positioning, showing the fiber optic light being block or absorbed.

FIG. 41 is a cross-sectional view of the urethral apparatus of FIG. 40taken along line 41-41'.

FIG. 42 is a view similar to FIG. 40 showing the urethral apparatus atanother stage of positioning and showing the fiber optic light beingreflected.

FIG. 43 is a cross-sectional view of the urethral apparatus of FIG. 42taken along line 43-43'.

FIG. 44A is a schematic flow diagram illustrating the electrical flowduring coupling of the insertion tool and urethral apparatus of FIG. 39.

FIG. 44B is a schematic flow diagram illustrating the electrical flowduring positioning of the insertion tool and urethral apparatus of FIG.39.

FIG. 45A is a schematic flow diagram illustrating the electrical flowduring coupling of the insertion tool and an alternative embodiment of aurethral apparatus that uses only one fiber optic strand and an opticaltransducer.

FIG. 45B is a schematic flow diagram illustrating the electrical flowduring positioning of the insertion tool and urethral apparatus of FIG.45A.

FIG. 46A is a sectional view of an alternate embodiment of a urethralapparatus that incorporates drug delivery.

FIG. 46B is sectional view of an alternate embodiment of the urethralapparatus shown in FIG. 46A with a flow-restrictor valve.

FIG. 47 is a sectional view of another alternate embodiment of aurethral apparatus that incorporates drug delivery.

FIG. 48 is a sectional view of an alternate embodiment of a urethralapparatus that incorporates internal valving for fluid flow control andshown in a first, closed stage of operation.

FIG. 49 is a sectional view of the embodiment of FIG. 48 showing thevalving components in a second, damping stage of operation.

FIG. 50 is a sectional view of the embodiment of FIG. 48 showing thevalving components in a third, open stage of operation.

FIG. 51 is a sectional view of the embodiment of FIG. 48 showing thefluid flow path.

FIG. 52 is a side view of the fluid flow director of FIG. 48.

FIG. 53 is an end view of the fluid flow director of FIG. 48.

FIG. 54A is an end view of an embodiment of the magnet of FIG. 48.

FIG. 54B is an end view of an alternative embodiment of the magnet ofFIG. 54A.

FIG. 55 is a sectional view of an alternate embodiment of a urethralapparatus that includes anchoring features for securing the apparatus inthe urethra.

FIG. 56 is a sectional view of an alternate embodiment of a urethralapparatus having anchoring features.

FIG. 57 is a sectional view of the embodiment of FIG. 55 positionedwithin the urethra with lines illustrating forces applied to theapparatus.

FIGS. 58A, 58B, and 58C show alternative embodiments for females ofurethral apparatuses having anchoring structures.

FIGS. 59A, 59B, 59C, 59D, and 59E show alternative embodiments for malesof urethral apparatuses having anchoring structures.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

I. GENERAL OVERVIEW

Disclosed below are various embodiments of apparatuses for urethralplacement. The disclosed embodiments provide functions that requireproper placement of the apparatus in the urethra. For example, inembodiments that are used for control of incontinence, it is requiredthat a proximal part of the apparatus be in or close to the bladder sothat urine can flow into an opening in the proximal end of theapparatus. These embodiments described below include a feature thatfacilitates proper placement of the apparatus.

II. EMBODIMENTS WITH MECHANICAL SENSING:

A. First Embodiment of a Urethral Apparatus

FIGS. 1-10 show a first embodiment of an apparatus 100. The apparatus100 is intended to be positioned in a urethra (shown in FIGS. 7-10) andto extend partially into a bladder (shown in FIGS. 7 and 9) of apatient. The patient may be either a male or female human, oralternatively, embodiments of the apparatus may be used in other mammalsor even in non-mammals, with suitable changes in dimensions.

Referring to FIGS. 1 and 2, the apparatus 100 includes a body 101 havinga wall 102 with an exterior surface 103. The body 101 has a generallytubular shape around axis 111. The body 101 has a distal portion 105terminating in a distal end 106 and a proximal portion 107 terminatingin a proximal end 108. (As used herein, the term "proximal" refers tothe end which is at or close to the bladder and the term "distal" refersto the end opposite the proximal end and farther away from the bladderwhen the apparatus is in place. The proximal end would be insertedfirst. This terminology convention applies as well to the insertiontool, described below.)

The cross sectional shape of the body 101 may be generally circular ormay be flattened to conform to the anatomical shape of the urethra. Thebody 101 has a generally tubular shape around an axis 111. The proximalportion 107 of the body 101 has at least one port 109 which may belocated at the proximal portion 107 or proximal end 108 to allow forurine flow into and through the apparatus. Alternately, the proximal end108 may have an open through-lumen to allow the apparatus to be used asan introducer for fluids, stents, or other apparatuses or to function asa temporary stent itself for diagnostic and therapeutic procedures inthe lower or upper urinary tract. The body 101 defines a passageway orlumen 101 that extends through the length of the body 101 from theproximal port 109 to a distal opening 115.

In one embodiment the apparatus 100 is produced using a compositeconstruction of a base tube and cast external features. A base tube isconstructed as a braid reinforced silicone tube using a stainless steelwire braid and Shore A 60 durometer silicone compound as the tubepolymer (tubing produced by New England Electric Wire Corp. Lisbon,N.H.). The internal diameter of the base tube is 0.160 inches using abraid core diameter of 0.180 inches. The external diameter of the basetube is 0.210 inches.

In one class of embodiments of the urethral apparatus 100, the body 101has an overall length such that the body 101 resides entirely within theurinary tract of the patient, preferably primarily within the urethra,except to the extent to which the proximal end 108 extends partially orcompletely into either the bladder or the bladder neck. In theseembodiments, the distal end 106 of the body 101 of the apparatus 100does not extend outside the urethra after it is positioned. In theseembodiments that are retained entirely within the patients' bodies,additional elements or capabilities may be provided, such as a fluidvalving or drug delivery, as described more fully below. In presentembodiments, the body 101 is less than 10 cm in length in versions foradult-sized male users and 5 cm in length for adult-sized female users,but more preferably less than 5 cm in length for female users.

In certain applications, such as certain short-term applications,alternate embodiments of the apparatus 100 can be employed in which theoverall length of the body 101 is greater than the above dimensions. Inthese embodiments, the distal end 106 of the body 101 extends outsidethe urethra while the proximal end 108 is positioned within the bladderor the bladder neck. In embodiments of the apparatus in which the distalend extends outside the body, the distal end 106 can be connected to afluid collection or introducer system.

The body 101 may be sized from about 10 French to 34 French toaccommodate the large range of urethral sizes from infants to adults.The exterior surface 103 of the body 101 is constructed of moldedsilicone or alternatively of latex. Alternative materials include moldedpolyurethane, polyethylene, polycarbonate, or other biocompatiblematerials.

B. First Embodiment of Insertion Tool.

Referring to FIGS. 1 and 2, the urethral apparatus 100 is releasablycoupled with an insertion tool 150 for placement and removal. Theinsertion tool 150 provides three functions. First, the insertion tool150 couples to the urethral apparatus 100 and aids insertion of theapparatus 100 into the urethra, bladder neck, or bladder. Second, theinsertion tool 150 completes the respective electrical circuits toprovide feedback that the urethral apparatus 100 is coupled with theinsertion tool 150. Third, the insertion tool 150 interfaces with theurethral apparatus 100 and completes the various electrical, optical,fluid, or mechanical circuits, channels, or linkages of the urethralapparatus 100 to provide feedback to the caregiver that the urethralapparatus 100 is properly positioned in relation to the bladder neck orbladder. These functions of the insertion tool 150 are described below.

Referring to FIGS. 1 and 2, the insertion tool 150 has a handle 151 anda linkage 152 that passes through a shaft 154. The linkage 152 isconnected to an actuating mechanism, such as a plunger 156, at a distalend 158 of the insertion tool and is connected to a deformable coupling160 at a proximal end 162 of the insertion tool 150. (In an alternativeembodiment (not shown) the locking mechanism can be a bayonet-typemechanism, which engages the alternate locking mechanism to maintain theplunger in a depressed position.) The deformable coupling 160 fits intoan inner recess 113 in an entrance channel 114 in the distal portion 105of the body 101 of the urethral apparatus 100, thereby locking theinsertion tool 150 with the apparatus 100. FIG. 2 shows the insertiontool 150 uncoupled from the apparatus 100 with the deformable coupling160 at the proximal end 162 of the insertion tool 150 in an uncompressedmode, and FIG. 5A shows the insertion tool 150 coupled to the urethralapparatus 100 with the deformable coupling 160 in a compressed mode.

C. Sensing Component.

Referring again to FIG. 1, the urethral apparatus 100 includes a sensingcomponent 112. In this embodiment, the sensing component 112 isassociated with the body 101, and in particular, the sensing component112 is located along the axial length of the body 101. The sensingcomponent 112 senses a change in the environment of the urethra or achange in a feature of the urethra as the apparatus is being positionedin the urethra. For example, the sensing component 112 may respond tochanges in anatomical features of the urethra as a portion of theapparatus 100 moves along the urethra and enters the bladder neck andbladder. The sensing component 112 does not necessarily measure anyparticular condition or feature but instead detects a change in acondition, parameter, or feature. For example, the sensing component 112may detect a change from a compressed state to an uncompressed state orto a less-compressed state, from an environment where outward force isregistered to an environment where the same force is either no longerregistered or is contained with less resistance, or from having onelight or sound reflection quality or parameter to an environment havinga different reflection quality (e.g., the urethra versus the bladderneck or the bladder). As such, the sensing component 112 can be atactile sensor, a pre-loaded spring, a force-sensitive contact, a photocell interacting with a fiber optic strand by radiating and receivingreflected light, a pair of fiber optic strands, a piezoelectrictransducer or a membrane switch, a pneumatic or hydraulic electrical ormechanical indicator, a strain gauge, an acoustical-reflection sensor, athermal couple, a thermistor, or a fluid-introduction port or fluidcircuit in combination with a movable element actuating electrical ormechanical components. Utilizing any of these or other sensingtechnologies to sense any of the features or conditions in the urethralenvironrnent, the sensing component 112 includes appropriate scaling sothat it can provide a positive indication when the apparatus is properlypositioned relative to the features of the urethral environment. Byappropriate scaling, the sensitivity of the sensing component isestablished so that it outputs a signal (preferably a single signal)indicating proper placement of the tubular body relative to the bladderneck and bladder. In this manner the sensing component distinguishes thechange in the sensed feature from the urethral background environment toprovide a signal indicating that the bladder neck or bladder have beenreached.

One embodiment of the sensing component 112 is described in conjunctionwith FIGS. 5A through 5C. This embodiment of the sensing component is amechanical-type sensor or pressure sensor. This embodiment of thesensing component 112 is responsive to compressive forces applied to aportion of the body 101 of the urethral apparatus 100.

The sensing component 112 comprises a first wall 123 and a second wall124. The first and second walls are formed of tubular parts of the body101 of the urethral apparatus 100 close to the proximal end 108. Thefirst wall 123 has shape-memory characteristics and assumes at leastfirst and second positions (compare, for example, FIGS. 7 and 8 withFIGS. 9 and 10). In this embodiment, the first wall 123 is resilient andflexible. The first wall 123 is formed so that it bows outward, as shownin FIG. 5A, in its at-rest condition. In this bowed condition, the firstwall 123 is spaced away form the second wall 124, as shown in FIG. 5A.However, when compressive forces are applied to the first wall 123, itdeflects to the flattened condition shown in FIG. 7. Movement from thebowed-out condition to the flattened condition causes a correspondingmovement of axial length of the first wall 123. Because the proximal end125 of the first wall is fixed, the distal end 126 of the first wall 123is caused to move proximally or distally as a result of the bowing outor flattening of the first wall 123.

Referring to FIGS. 5A, 5B, and 5C, lead wires 117 and 118 interconnectconducting surfaces 116a and 116b of the apparatus first contact collar116 to conducting surfaces 120a and 120b, respectively, of an apparatussecond contact collar 120. As shown in FIG. 5B, the apparatus conductingsurfaces 120a and 120b are separated by apparatus non-conductingsurfaces 120c and 120d. The distal end 126 of the first wall 123 has anapparatus third contact component 122 which has a continuous metalizedconducting surface 122a. Completion of an electrical circuit between theapparatus second contact collar 120 and the apparatus third contactcomponent 122 provides a feedback signal to the person positioning theapparatus, such as the caregiver, that the urethral apparatus is in theurethra. Conversely, opening the electrical circuit between theapparatus second contact collar 120 and the apparatus third contactcomponent 122 provides a feedback signal that the urethral apparatus isproperly positioned in the bladder neck or bladder (explained in moredetail below). This allows the circuit between the apparatus secondcontact collar 120 and the apparatus third contact component 122 to bealternately opened or closed, depending on the position of the urethralapparatus 100 along the urinary tract.

FIGS. 6A and 6B show the apparatus first contact collar 116 in moredetail and show conductive surfaces 116a and 116b separated bynonconductive surfaces 116c and 116d. In an alternative embodiment, theapparatus first contact collar 116 can be replaced with a contact filmhaving conducting areas corresponding to the conductive surfaces 116aand 116b and non-conducting areas corresponding to the surfaces 116c and116d.

D. Insertion Tool Indicator Unit.

The sensing component 112 in the urethral apparatus 100 works inconjunction with the insertion tool 150. Referring to FIGS. 2 and 3, theproximal end 162 of the insertion tool 150 includes an atraumaticproximal tip 172 and an insertion tool contact collar 170. The toolcontact collar 170 is composed of three conductive areas 170a, 170b, and170c. The contact collar 170 has an oval cross-sectional shape.

The insertion tool 150 includes an indicator unit 164 (FIG. 1). Theindicator unit 164 uses any of various visual, audible, or othersignaling indicators (e.g., a first light 165, a second light 166, andan alarm 167) that (1) receive electrical feedback that the urethralapparatus 100 and the insertion tool 150 are coupled and (2) receivefeedback from the sensing component 112 that the apparatus 100 isproperly positioned. This information is relayed along the tool shaft154 through a lead bundle 168, for example, to the indicator unit 164where it is observable by the caregiver or the patient. The indicatorunit in the insertion tool 150 is powered by a battery (not shown).

(In alternative embodiments, all or part of the functions of theindicator unit may be located at the distal end of the urethralapparatus. Such embodiments may be used in conjunction with an insertiontool that is used to facilitate positioning or may be used withoutinsertion tools. In embodiments of the urethral apparatus in which thedistal portion of the body of the urethral apparatus extends outside ofthe urethra during use, the indicator unit may be incorporated into thedistal portion and may include appropriate audible, visual, or othersignaling to indicate that the apparatus is properly positioned.)

E. Operation--placement.

Referring to FIG. 2, in the uncoupled mode, the deformable coupling 160of the insertion tool 150 has a first diameter 174 and a first width 175(as shown in FIGS. 4A and 4B) and is able to pass through the tapereddistal end 106 of the tubular body 101. The proximal end 162 of theinsertion tool 150 is inserted into the entrance channel 114 and intothe inner recess 113, which has a greater vertical cross-sectional area.The deformable coupling 160 is compressed by an actuating linkage 152using the plunger 156. The vertical diameter of the coupling 160 isextended to a second, larger diameter 176 and a second width 177 (FIG.4B and 4C), thereby pressing the deformable coupling 160 into the outerextremities of the inner recess 113 of the urethral apparatus andpressing the conductive areas 170a, 170b, and 170c of the insertion toolcontact collar 170 against the conductive surfaces 116a and 116b of theapparatus first contact collar 116 (FIG. 5A). This contact activates thefirst light 165 of the indicator unit 164 providing a feedback signalthat the insertion tool 150 and the urethral apparatus 100 are coupled.The two units are now securely engaged together and are ready forinsertion into the urethra. As shown in FIG. 1, a biasing force appliedto the plunger 156 (and thereby to the linkage 152) by the spring 178helps to maintain the deformable coupling 160 in a locked or coupledmode, and the stop 179 aids to limit travel of the plunger 156 therebycontrolling the diameter of the deformable coupling 160. Further, alocking mechanism can be provided, such as a simple screw 180 and nut181 combination, to secure the plunger shaft 182 in an uncompressedmode.

FIGS. 7 and 8 show the coupled insertion tool 150 and urethral apparatus100 being inserted into the urethra 40. In FIGS. 7 and 8, the urethralapparatus 100 is passing through the urethra 40 and approaching thebladder neck 42. In this position, the sensing component 112 isresponsive to an environment that is relatively consistent within theurethra 40. In this example, the sensing component 112 is in a flattenedconfiguration, and the apparatus second contact collar 120 is in contactwith the apparatus third contact component 122, which is part of thesensing component 112. This circuit between the apparatus second contactcollar 120 and the apparatus third contact component 122 is maintainedwhile the proximal end 108 of the urethral apparatus 100 is still withinthe urethra 40. As the coupled urethral apparatus 100 and insertion tool150 are advanced through the urethra 40, the sensing component 112 isdeformed due to the compressive forces exerted by the continuous surfaceof the urethra 40.

As shown in FIGS. 9 and 10, when the urethral apparatus 100 moves intothe larger diameter channel of the bladder neck 42 or bladder 44, thesensing component 112 undergoes a change in shape. This change causesthe apparatus third contact component 122 to move away from theapparatus second contact collar 120, opening that circuit and therebysending a feedback signal to the person positioning the urethralapparatus, such as the caregiver, that the urethral apparatus 100 is inproper position in relation to the bladder neck 42. The insertion tool150 can now be uncoupled from the urethral apparatus 100. FIG. 9 showsthe insertion tool 150 uncoupled from the urethral apparatus 100,leaving the urethral apparatus 100 in proper position in relation to thebladder neck 42 and bladder 44. The proximal end 162 of the insertiontool 150 may have a tapered transition 184 from the shaft 154 to thedeformable coupling 160 to ease withdrawal of the insertion tool 150.

F. Operation--Removal of apparatus.

Removal of the urethral apparatus 100 is accomplished using the abovesteps in reverse order. The linkage 152 of the insertion tool 150 isactuated by the plunger 156 and locked to maintain the deformablecoupling 160 in the first diameter 174 and the first width 175. Theinsertion tool 150 is inserted into the urethra until it engages thedistal end 106 of the urethral apparatus 100. The proximal end 162 ofthe insertion tool 150 is further inserted into the entrance channel 114of the distal end 106 of the urethral apparatus 100 until the toolcontact collar 170 of the insertion tool 150 engages the apparatus firstcontact collar 116. This engagement can be confirmed by observingactuation of the first light 165. The deformable coupling 160 is thenchanged to the second, larger diameter 176 and the second width 177 byreleasing the plunger 156 thereby locking the insertion tool 150 to theurethral apparatus 100. Once coupled, removal of the tool and urethralapparatus can proceed by pulling on the distal end of the tool.

G. Use of an Insertion Sleeve.

In alternative embodiments, the coupled or joined urethral apparatus 100and insertion tool 150 can be inserted in the urethra with the aid of aninsertion sleeve (not shown), which is inserted in the urethra 40 eitherprior to or simultaneously with the joined urethral apparatus and tool.The insertion sleeve can be a short or a long sleeve, or an evertingsleeve that may aid in reducing the introduction of bacteria higher intothe urethra or bladder. The sleeve has a length such that it does notinterfere with the sensing component 112 on the body of the urethralapparatus. The sleeve may also have a longitudinal line of weakness tofacilitate removal of the sleeve, for example by tearing. Those skilledin the art will realize that a coating on the sleeve, preferablyincluding lubricating and antibacterial substances, may be used to aidin insertion within the urinary tract.

H. Alternative Embodiment of Insertion Tool

FIGS. 11 through 15 show an alternative embodiment 250 of the insertiontool, which can be used for placement of the urethral apparatus 100. Theinsertion tool 250 provides for an axial orientation of the caregiver'shand during insertion and removal. In this embodiment of the insertiontool 250, the plunger and locking mechanism are integrated within ahandpiece housing 251. A proximal end 262 of the insertion tool 250 hasan atraumatic distal tip 272, which is interconnected with a cable orother linkage 252 that passes through a shaft 254 of the insertion tool250. The linkage 252 is connected to a plunger 256 and has a biasingspring 278 (best shown in FIG. 12). A sleeve 257 serves to center thespring 278 over the linkage 252 (FIG. 13). As the plunger 256 is movedforward and backward, it engages a stop 279 (FIG. 14), which secures adeformable coupling 260 either in an engaged or disengaged position withthe urethral apparatus 100. A battery 259, which supplies power for theinsertion tool 250, is inserted through a distal end 258 of theinsertion tool 250 and is held in place with a nut 281 and a batteryspring 261. A ground contact strip 263 for the battery 259 is locatedadjacent to and in contact with the battery spring 261 and with a groundlead 269. A positive contact 283 for the battery 259 is connected to apositive lead 284 and is connected to the circuitry in an indicator unit264. FIG. 12 also shows a lead bundle 268 consisting of individual leads268a, 268b, and 268c (best shown in FIG. 15) that carry feedback signalsindicating proper coupling and positioning. The individual leadsterminate within the indicator unit 264 which is further detailed in thecircuit flow diagrams and descriptions discussed below.

The indicator unit 264 is joined to the shaft 254 of the insertion tool250 with a slip connector 255. The slip connector 255 allows the distalend 258 to be rotated to aid in coupling the insertion tool 250 with theurethral apparatus 100 and to aid insertion of the coupled tool andurethral apparatus through the urethra.

Referring to FIG. 15, the insertion tool 250 has an insertion toolcontact collar 270 close to its proximal end 262. (This contact collar270 may be similar to the contact collar 170 of the insertion tool 150in the previously described embodiment.) The contact collar 270 includesthree conducting surfaces 270a, 270b and 270c (FIG. 16B), whichinterface with the conducting surfaces 116a and 116b of the firstcontact collar 116 of the urethral apparatus 100 to complete a circuitthat indicates proper coupling of the insertion tool 250 with theurethral apparatus 100. The conductive surfaces 270a, 270b, and 270c areconnected to the three electrical leads, 268a, 268b, and 268c,respectively. These leads are located within the shaft 254 of theinsertion tool 250 and terminate within the indicator unit 264 atelectrical contacts that communicate with a first light 265, a secondlight 266, and an alarm 267.

The electrical circuit flows during coupling and insertion arediagrammed in FIGS. 16A and 16B. The circuit flow during coupling isshown in FIG. 16A. The battery 259 is connected to a switch 285 at afirst contact 286 by the positive lead 284. A second contact 287 and theconductive surface 270b are interconnected by the lead 268b. When theinsertion tool is engaged with or coupled to the urethral apparatus 100,an electrical connection between the insertion tool conductive surfaces270b and 270c is made when each comes in electrical contact with theconductive surface 116a of the urethral apparatus 100. In this coupledmode, the first light 265 is activated.

Also receiving power through the switch 285 is an inverter 294 and arelay 295, which receive power through a third switch contact 288 and alead 268d. The switch 285 can be in one of two positions for receivingfeedback. The first position is used during coupling, and the secondposition is used during positioning.

After the urethral apparatus 100 and the insertion tool 250 are coupled,the switch 285 is moved to a second position, and the first light 265remains lit. FIG. 16B illustrates the circuit flow during insertion andpositioning. The sensing component 112 is compressed against the outersurface of the body 101 such that the conductive surface 122a of thethird contact component 122 electrically interconnects the secondconducting surfaces 120a and 120b of the second contact collar 120. Theleads 117 and 118 electrically interconnect the first contact collar 116with the second contact collar 120. Both the first and second lights 265and 266 are on unless the switch 285 is in the off position. Theinverter 294 translates the electrical signal returning through the lead268a to indicate when the sensing component 112 becomes uncompressed,i.e. the third contact component 122 located on the sensing component112 becomes electrically disconnected from the conducting surfaces 120aand 120b when the urethral apparatus 100 enters the bladder, and anelectrical signal is transferred through the lead 268e to the switch 285to activate the second light 266 and/or alarm 267. The second light 266and the alarm 267 may be selectively activated depending on the user'ssetting of the switch 285.

In a present embodiment, the switch 285 has four positions. In a firstposition, the electrical circuitry is off. In a second position (forcoupling), the first light 265 is activated when the circuits arecompleted between the insertion tool contact collar 270 and the firstcontact collar 116 of the urethral apparatus 100. When the switch 285 isin a third position (for positioning or insertion), the input contact289 and the light contact 290 are interconnected and the second light266 activates indicating entrance to a body passageway with increasedarea (e.g., diameter). In a fourth position, the input contact 289 isinterconnected to the light/alarm contact 291 and the second light 266and the alarm 267 are activated, thereby indicating entrance to a bodypassageway of increased area (i.e. diameter). The input contact 289 isactivated either directly via the voltage source, or with an optionalrelay 295.

Those skilled in the art will appreciate that the inverter 294 reversesthe activation of the second light 266 (or the alarm 267) relative tothe operation described in connection with the first embodiment of theinsertion tool. Instead of being turned off when a current path betweenthe apparatus conducting surfaces 120a and 120b and the apparatuscomponent surface 122a is interrupted, the inverter 294 causes thesecond light 266 (or the alarm 267) to be turned on when the currentpath is interrupted. Thus, the inverter 294 is provided to effect thisalternative mode of operation. Accordingly, it is understood that theuse of the inverter is optional depending upon the mode desired.

I. Second Embodiment of the Urethral Apparatus:

FIG. 17 shows another embodiment 100A of the urethral apparatus. Theurethral apparatus 100A includes a tubular body 101A having a proximalportion 107A terminating in a proximal end 108A. In this embodiment, asensing component 112A is comprised of a preformed, shape-memory portionincorporating internal electrical switching. The proximal portion 107Aincludes a preformed portion 131 A. The preformed portion 131A isflexible and resilient and has an other-than-straight shape when atrest. A slidable contact 132A is fixed distally at a position 134A anddisplaced relative to a proximal contact pair 135A as deformation of thepreformed portion 131A occurs upon entry into the bladder neck orbladder. This displacement causes the proximal contact pair 135A toopen, thus opening an electrical circuit through the apparatusconductive leads 117A and 118A, which interconnect the proximal contactpair 135A and the apparatus first contact collar 116A, which is incontact with the insertion tool 150 (or 250), thereby activating asignal on the indicator unit 164 (or 264) thereof Optionally, theapparatus proximal contact pair 135A can be located in a more distalposition near the apparatus first contact collar 116A. In an alternativeembodiment, the preformed portion 131A is incorporated within orutilized with an anchoring mechanism, which provides for an electricalfeedback to give an indication of entry into the bladder neck or bladderand to confirm proper positioning in relation to the bladder neck orbladder.

J. Third Embodiment of Urethral Apparatus:

FIGS. 18, 19A, and 19B show another alternate embodiment of a urethralapparatus 100B. In this embodiment, a sensing component 112B comprisesconductive contact terminals that form a switch that can sense entryinto a bladder neck or bladder. A proximal portion 107B of a body 101Bof the urethral apparatus 100B includes a switch 127B that displaces aninternal contact pair 128B (shown in the circuit flow diagram of FIGS.19A and 19B) as the proximal portion 107B of the urethral apparatus 100Bcontaining the switch 127B enters the bladder neck or bladder. Thisdisplacement causes the contact pair 128B to open, thus opening theelectrical circuit through the conductive leads 117B and 118B, whichinterconnect the switch 127B and a first contact collar 116B, which isin contact with the insertion tool 150 (or 250), thereby activating asignal on the indicator unit 164 (or 264) thereof

III. EMBODIMENTS WITH ACOUSTIC SENSING:

A. First Embodiment of a Urethral Apparatus with Acoustic Sensing:

As mentioned above, the sensing component can be designed to sensechanges in light, pressure, force, vibration, compression, heat, orother sensed conditions. These alternative embodiments are describedbelow.

Referring to FIGS. 20, 21A, and 21B, there is shown an embodiment of aurethral apparatus 200 that utilizes a acoustic sensing component 212 togenerate an indication of proper placement. The embodiment of FIGS. 20,21A, and 21B functions similarly to the embodiment in FIG. 18 exceptthat the switch 127B of FIG. 18 is replaced with an acousticaltransducer 227. The acoustical transducer 227 is preferably apiezoelectric acoustical transducer, but alternatively, may be amagnestrictive acoustical transducer. The acoustic transducer 227 ispreferably located within the body 201 of the urethral apparatus 200.The acoustic transducer 227 is activated to generate a pulsed modesignal and receive an acoustical signal.

FIG. 21B shows the electrical current flow path during positioning ofthe embodiment of the urethral apparatus 200 shown in FIG. 20 operatingin a pulsed echo mode. Current flows from a third contact 288 of aswitch 285 through a lead 268d to a voltage conditioner 280. The voltageconditioner 280 (which may optionally be a component of the pulsegenerator/time delay 282) provides for the necessary preamplification.Following voltage preamplification, the pulse generator/time delay 282provides for the formation of the excitation impulse wave form used toresonate the acoustical transducer 227. The impulse wave form istransmitted through a lead 268f to a conducting surface 270b of theinsertion tool contact collar 270 and then to the conductive surface216a of the first contact collar 216 of the urethral apparatus 200. Thewave form is then transmitted through the lead 217 to the acousticaltransducer 227.

The acoustical transducer 227 is resonated at the characteristicfrequency of the transducer which may range from as low as approximately1 Kilohertz to as much as approximately 100 Megahertz. In oneembodiment, a range of resonate frequencies within two orders ofmagnitude of 1 Megahertz is appropriate. The resonate frequency of thetransducer is dependent on its material properties and thickness. Thepulse generator wave form is a triangular or square wave with amplitudesranging up to approximately 100 volts. The pulse generator/time delay282 provides for an excitation voltage followed by a wait state prior tore-initiation of the next resonance. The resonance of the transducer 227provides for an energy transmission into the adjacent materials; thistransmission is in the form of an acoustical beam as the energy istransmitted through the adjacent material at the speed of sound of thematerial itself.

The surrounding materials either reflect, absorb, or transmit theenergy. The energy that is reflected provides an indication of thesurrounding environment. The initial reflections which impact theacoustical transducer surface 204 following the completion of theresonance from the initial excitation re-resonate the transducer 227.This resonance produces an electrical potential (voltage) at thesurfaces which is conducted back through leads 217 and 218 to theconductive surfaces 216a and 216b of the first contact collar 216,through the conductive surfaces 270a and 270b of the insertion toolcontact collar 270, and to the pulse generator/time delay 282 throughleads 268a and 268f.

The voltage differential between the leads 268a and 268f diminishessubstantially during the pulsed echo cycle when the acousticaltransducer 227 enters the regions of increased area in the bladder neckand bladder. Because the distance from the acoustical transducer surface204 to the body tissue surface increases at the bladder neck andbladder, there is a substantial reduction in the reflected energiescompared to the more intimate contact within the tighter areas of thebody such as the urethra.

The voltage threshold comparator and a relay 299 register the peakreflected voltage. When the average peak voltage produced by thereflected energy is less than the predetermined threshold (oralternatively a differential between high and low reflected peakvoltages), an input contact 289 is activated either directly via thevoltage source, or with an optional secondary relay (not shown). Whenthe switch 285 is in a position in which the input contact 289 and thelight contact 290 are interconnected, the second light 266 lightsindicating entrance to a body cavity with increased area. Alternatively,when the switch 285 is in the position where the input contract 289 andthe light/alarm contact 291 are interconnected, both the second light266 and the alarm 267 are activated.

Upon receipt of the pressure wave on the acoustical transducer 227, avoltage is generated and transmitted to the insertion tool 250 externalto the patient's body where the wave form is processed using the analogor digital circuitry contained within insertion tool 250. The distanceaway from the transducer to the surface of the urethra, bladder neck, orbladder is determined by the elapsed time from the completion of agenerated signal until the first wave return. Alternatively, thedistance from the transducer to the surface of the urethra, bladderneck, or bladder is determined by the change in intensity of thereflected acoustical waves. In either case, a change in state becomesapparent by the acoustical reflections as the apparatus 200 enters theor bladder. The insertion tool 250 then generates an appropriateaudible, visual, analog, or other signal of this change.

B. Alternate Embodiments of Insertion Tool:

Several other embodiments of the sensing component are described belowthat use other methods of initiating feedback to the caregiver that theurethral apparatus is properly positioned. Among these other embodimentsare the use of one- and two-way fluid flows, fiber optics, electricalresistance, thermoelectric semiconductors, and two-transducer acousticmechanisms. These embodiments use an alternate embodiment of theinsertion tool electrical contact collar.

Referring now to FIGS. 22A through FIG. 22D, an alternate embodiment ofan insertion tool contact collar 270A for use with the urethralapparatus first contact collar (e.g., 116 or 216) allows for additionalconvenience when coupling. Both contact collars include conductingsurfaces and non-conducting surfaces that form circuits to indicateeither coupling of the insertion tool with the urethral apparatus orproper positioning within the bladder neck or bladder. In furtherembodiments, both contact collars are oval-shaped and have additionalmating contact points to accommodate various fluid-flow pathways andfiber optics connections. For convenience, there are twice as many ofthese additional mating contact points on the insertion tool contactcollar 270A as there are mating contact points on the urethral apparatusfirst contact collar (116 or 216) so that either of the two 180-degreeorientations are functional.

FIG. 22A shows the proximal portion of the insertion tool 250 andfurther illustrates the assembly of the contact collar 270A to thecontact collar housing 270.5. Also shown in the figure is the contactcollar 116 (or 216) of the urethral apparatus 100 (or 200) to illustratehow the contact collars of the insertion tool 250A and the urethralapparatus 100 (or 200 and following embodiments) interface with oneanother.

The table below shows the number and type of the contact points ormating contact points provided on the insertion tool contact collar270A, the urethral apparatus first contact collar 116 (or 216), and thenumber of leads for the various embodiments in this disclosure. Asmentioned above, the number of contact points or ports on the insertiontool contact collar 270 may be doubled for convenience when coupling.

    ______________________________________                                                  Insertion Tool                                                                            Urethral Apparatus                                                                         Urethral                                             Contact collar                                                                            Contact collar                                                                             Apparatus                                  Embodiment                                                                              Tool Contacts*                                                                            Insertable Contacts                                                                        Leads                                      ______________________________________                                        Electrical Switch                                                                       3 electrical                                                                              2 electrical 2 electrical                               Acoustic (                                                                              3 electrical                                                                              2 electrical 2 electrical                               1 transducer                                                                  Fluid - 1 way                                                                           2 electrical 1 fluid                                                                      1 electrical T fluid                                                                       1 fluid port                               flow      port        port                                                    Fiuid - 2 way                                                                           2 electrical 2 fluid                                                                      1 electrical 2 fluid                                                                       2 fluid ports                              flow      ports       ports                                                   Electrical                                                                              3 Electrical                                                                              2 electrical 2 electrical                               Resistance                                                                    Thermoelectric                                                                          3 electrical                                                                              2 electrical 2 electrical                               Semiconductor                                                                 Fiber Optic-                                                                            2 Electrical                                                                              1 electrical 2 fiber                                                                       2 f optical                                Fiber Optic                                                                             2 Fiber Optic                                                                             optic                                                   Fiber Optic-                                                                            4 Electrical                                                                              3 electrical 2 electrical                               Photocell 1 fiber optic                                                                             1 fiber optic                                                                              1 fiber optic                              Acoustic  5 electrical                                                                              4 electrical 4 electrical                               (2 transducer)                                                                ______________________________________                                         (*number of contact points can be doubled.)                              

C. Second Embodiment of a Urethral Apparatus with Acoustic Sensing:

FIG. 23 illustrates a second acoustic embodiment (apparatus 200A). Inthis embodiment, a sensing component that uses acoustic sensing in showngenerally at 212A. This embodiment utilizes two magnestrictive, orpreferably, piezoelectric acoustical transducers 227A(1) and 227A(2) onan exterior surface 203A of the urethral apparatus 200A. Thesetransducers 227A(1) and 227A(2) are activated to respectively generateand receive a continuous mode acoustical signal. This embodiment issimilar to the first acoustic embodiment except that in this embodiment,a first transducer 227A(1) generates a continuous mode acoustic signalrather than a pulsed signal, while a second transducer 227A(2) receivesthe signal. Electrical leads 217Aa, 217Ab, 218Aa, and 218Ab carry anelectrical potential (voltage) to and from the transducers 227A(1) and227A(2), respectively, and are interfaced with electrical leads 268 inthe insertion tool 250 through the contact collars 270 and 216A toprovide for a feedback signal. Circuitry in the insertion tool issimilar to that shown for the first acoustic embodiment (see FIG. 21A)except that the pulse generator is replaced by a continuous modegenerator.

As the urethral apparatus 200A is inserted into the urethra, thesurrounding materials either reflect, absorb, or transmit the energy.Acoustic energy is emitted by the first acoustical transducer 227A(1),reflected by the urethral wall, and received by the second transducer227A(2), which resonates and produces an electrical potential (voltage)that provide an indication of the surrounding environment. This voltagediminishes substantially when the transducers enter the bladder neck andbladder where the distance from the transducer surfaces to the bodytissue surface increases and causes a substantial reduction in thereflected energies compared to the more intimate contact within tighterareas of the body such as the urethra.

In an alternate embodiment, the two transducers are placed facing eachother, separated by a non-reflective, shape-memory member similar tothat used in the fiber optic embodiments, described below. A change isacoustic signal is noted when the proximal end of the urethral apparatuscarrying the transducers enters the bladder neck and bladder, therebyallowing the shape memory member to be displaced outward which, in turn,permits an unobstructed face-to-face orientation of the two transducers.

III. EMBODIMENTS WITH FLUID FLOW SENSING:

Pressurized fluid flow may be used to provide for position feedback toascertain that the urethral apparatus is properly positioned. Fourapproaches using pressurized fluids in combination with an insertiontool and urethral apparatus are described below. The first threeapproaches provide a one-way flow of fluid from an insertion tool,through the urethral apparatus, and into the urethra, bladder, or afluid reservoir located in urethral apparatus. This flow can berestricted to varying degrees. In these embodiments, as the coupledinsertion tool and urethral apparatus pass through the urethra, fluidflow is restricted because of the urethra. However, as the proximalportion of the urethral apparatus enters the bladder neck or bladder,the flow becomes less restricted. This change in fluid restriction isdetected by circuitry in the insertion tool. The fourth approach,described below, does not permit fluid to escape into the urethra andbladder, but incorporates a two-way flow of fluid from the insertiontool, through the urethral apparatus, and back to the insertion tool.

A. First Embodiment of a Urethral Apparatus with Fluid Flow Sensing:

A first fluid flow embodiment is shown in FIGS. 24, 25a, 25b, 26a and26b. A urethral apparatus 300A provides for a limited passage of fluidinto the urethra or bladder. In this embodiment, the sensing componentis shown generally at 312A. In this embodiment, fluid is allowed to passfrom an insertion tool 350 and into a urethral apparatus 300A. The fluidis under pressure in a fluid reservoir 353 that is contained within theinsertion tool 350. Pressure can be applied by a thumb screw and pistonin combination with a biasing spring 353.5 located on the distal end ofa handpiece housing 351. Fluid flows through a fluid passageway 373a,through a passageway port 374, against the a flexible conduit wall 375which contacts a normally closed, pressure-responsive membrane switch376, and through a fluid passageway 373b that extends through a shaft354.

When fluid is in stasis due to resistance or complete retention offluid, the normally closed membrane switch 376 is electrically open.When the fluid pressure diminishes due to a dynamic fluid state, theflexible conduit wall collapses under the pressure of the normallyclosed membrane switch 376. The fluid then flows through a matingcontact point 371 of an insertion tool contact collar 370 through acontact port 334A of the urethral apparatus 300A, through a passageway311A, and out through a apparatus port 313A, which could be a porous ormicroporous membrane. The fluid is expelled into the urethra, thebladder neck, or the bladder, depending upon the location of the coupledinsertion tool 350 and apparatus 300A.

The change in restriction of flow is detected by the normally closedmembrane switch 376. As the apparatus 300A enters the bladder neck orbladder, the fluid encounters less pressure due to the lack of surfacecontact with the urethra. Since the source of this fluid pressure iswithin the insertion tool 350, the membrane switch 376 detects the lowersystem pressure. The pressure-responsive, normally closed membraneswitch 376 then returns to the unengaged position and closes theinternal contacts, thus completing a circuit between the contacts 377aand 377b, the energizing input contact 389, and the second light 366.Depending on the position of the switch 385, either the light only, orthe light and alarm, gives an indication that the proximal portion 307Aof the urethral apparatus 300A has entered the bladder neck or bladderas previously described in the other embodiments. The input contact 389is activated either directly via the voltage source or with an optionalsecondary relay (not shown).

B. Second Embodiment of a Urethral Apparatus with Fluid Flow Sensing:

Referring to FIG. 27, there is shown a second embodiment 300B of aurethral apparatus that uses fluid-flow for sensing. In this embodiment,the sensing component is shown generally at 312B. This embodimentprovides for a limited passage of fluid into the bladder neck or thebladder when a proximal portion of the apparatus 300B containing arestricted apparatus port 313B enters the bladder neck or bladder. Thisconfiguration is similar to the first fluid-flow embodiment 300A exceptthat no fluid is allowed to pass into the urethra during insertion dueto the physical contact of the urethra on the flow restrictor valve 315Bthat thereby closes the apparatus port 313B. The system mechanics andelectronics function similarly to the first fluid-flow configuration.

C. Third Embodiment of a Urethral Aparatus with Fluid Flow Sensing:

A third embodiment of a urethral apparatus 300C using a fluid-flowconfiguration is shown in FIG. 28 through FIG. 29B. In this embodiment,the sensing component is shown generally at 312C. This embodimentprovides for fluid feedback without the introduction of fluid intoeither the urethra, bladder neck, or bladder by providing for a one-wayfluid flow from the insertion tool 350 into a fluid reservoir 319Clocated in the urethral apparatus 300C. Adjacent to the fluid reservoir319C is a volume-deformable member 321C. As in the first two fluid-flowconfigurations, the fluid is under pressure in the reservoir 353contained within the insertion tool 350. This fluid flows through thefluid passageway 373a and 373b, through the shaft 354, then through themating contact point 371 of the insertion tool contact collar 370,through a contact port 334C of the urethral apparatus 300C, through theapparatus passageway 311C and the port 313C, and into a fluid reservoir319C As the insertion tool 350 and the urethral apparatus 300C areintroduced through the urethra, the volume-deformable member 321C is ina flattened profile, as shown in FIG. 29a. When the portion of theurethral 300C containing the volume-deformable member 321C enters thebladder neck or bladder, fluid pressure within the system causes thevolume-deformable member 321C to deform to a second, larger profile asshown in FIG. 29b, thus lowering fluid pressure within the circuit. Thischange in fluid pressure causes the pressure-responsive, normally closedmembrane switch 376 to return to the undeflected position, thuscompleting a circuit between the contacts 377a and 377b and theenergizing input contact 389 and the second light 366. The systemelectronics function similarly to the first two fluid-flowconfigurations.

D. Fourth Embodiment of a Urethral Apparatus with Fluid Flow Sensing:

A fourth embodiment of a urethral apparatus 300D that uses fluid-flowsensing is shown in FIG. 30A through FIG. 33B. This embodiment alsoprovides for fluid-initiated feedback without the introduction of fluidinto either the urethra, bladder neck, or bladder by providing for atwo-way fluid flow from the insertion tool 350 through the urethralapparatus 300D and back to the insertion tool 350. In this embodiment,the sensing component is shown generally at 312D. Like the otherembodiments of the fluid-flow configurations, the fluid, which is underpressure in the first fluid reservoir 353a that is contained within theinsertion tool 350, flows through the shaft 354 and into the urethralapparatus 300D. In this embodiment, however, fluid is allowed to flowthrough an input passageway 311Da of the urethral apparatus 300D andreturn through a return passageway 311Db. The input passageway 311Da andthe return passageway 311Db are interconnected (as illustrated in FIG.32) distal to a depressible contactor 329D, allowing for fluid flow inthe fluid circuit when a depressible contactor 329D is open, butpreventing fluid flow in the circuit when the depressible contactor 329Dis depressed. The depressible contactor 329D is located on the surfaceof the urethral apparatus 300D and is responsive to the physical contactof the urethra. The depressible contactor 329D serves to restrict theflow of fluid within the fluid circuit by preventing the return flowwhile the insertion tool 350 and apparatus 300D are being insertedthrough the urethra.

When the portion of apparatus 300D containing the depressible contactor329D enters either the bladder neck or the bladder, the depressiblecontactor 329D is free to move outward, (FIG. 30B) thus allowing thefluid within the fluid circuit to return through the return passageway311Db and collect in a second fluid reservoir 353b in the insertion tool350. This change in fluid pressure causes the pressure-responsive,normally closed membrane switch 376 to return to the unengaged position,thus completing a circuit between contacts 377a and 377b and energizingthe input contact 389 and the light 366. The system electronics functionsimilarly to the first three fluid-flow configurations.

IV. EMBODIMENTS WITH ELECTRICAL RESISTANCE SENSING:

Referring to FIG. 34, there is shown an embodiment of a urethralapparatus 400 that uses electrical resistance measurement for positionsensing. In this embodiment, the sensing component is shown generally at412. The electrical resistance between two spaced-apart locations alongthe urethra will differ from the resistance across the same distancewithin an aqueous fluid such as urine. For this reason, the embodimentof the urethral apparatus 400 includes two, spaced electrical contacts(a first contact 428a and a second contact 428b positioned along thebody 401 thereof. These electrical contacts allow for the passage of aminute current between them as apparatus 400 is installed. The urethraitself allows an electrical conduction as the apparatus 400 is fedthrough the urethra. When the electrical contacts 428a and 428b reachthe or bladder, the electrical resistance between the contacts changesas the apparatus 400 enters a pool of urine in the bladder neck orbladder. This change may be detected electronically with relativelysimple analog or digital circuitry and thus activate a feedback signal.

FIGS. 35A is a circuit flow diagram showing the current flows duringcoupling for this embodiment and aid to further explain the embodiment.FIG. 34B is circuit flow diagram showing the current flows duringpositioning. The current flows from a battery 459, through a positivelead 484, to a switch 485 in the insertion tool 450, then through a lead468b to a voltage conditioner 480, which provides the correct voltage.The current flows through an electrical lead 468f, through the contactcollars 470 and 416, and through an electrical lead 417 in the urethralapparatus 400 to a first contact 428a on or near the surface 403 of thebody 401 of the urethral apparatus. The current is then conducted acrossthe conductive media of the urethra or urine to a second contact 428b,through an electrical lead 418, through the contact collars 416 and 470,and back through the electrical lead 468a in the insertion tool 450 to avoltage threshold comparator and relay 499. When the portion ofapparatus 400 that contains the first contact 428a and second contact428b enters the bladder neck or bladder and is situated in a pool ofurine as described above, the change in electrical resistance isdetected by the voltage threshold comparator and relay 499 due to theresultant change in voltage. The voltage threshold comparator and relay499 then compares this voltage with the predetermined, preset voltage.When the voltage value correlates with the preset range, the voltagethreshold comparator and relay 499 energizes the input contact 489through the lead 468e with the line voltage from the battery 459.Depending on the position of the switch 485, either the light only, orthe light and alarm gives an indication that the urethral apparatus 400has entered the bladder neck or bladder as previously described in otherembodiments.

V. EMBODIMENTS WITH THERMOELECTRIC SENSING:

Referring to FIGS. 36 through 38B, there is shown an alternativeembodiment of a urethral apparatus 500 that uses thermoelectric coolingto provide for position feedback. The position of the urethral apparatusin the urinary tract is ascertained in response to feedback from theconduction of current through a thermoelectric module. In thisembodiment, the sensing component is shown generally at 512. Thethermoelectric module typically is composed of one or more pairs(couples) of semiconductors of Bismuth Telluride that has beennegatively or positively doped. The pairs of semiconductor are in athermally parallel circuit and in an electrical serial circuit. When alow-voltage, direct current is applied to the semiconductor pairs, heatenergy is absorbed to one surface, which causes it to become cool, andheat energy is conducted through the semiconductor electrically to theopposite surface, which becomes thermally elevated in temperaturecausing a liberation of heat to that environment. For this reason thethermoelectric heat transfer effectively performs the function oftransferring heat from a donor surface to a receptacle surface. The rateof heat transfer is determined by the semiconductor characteristics aswell as the electrical power being transferred through the semiconductorpairs. Given a constant direct voltage, the current increases when moreheat is being transferred, and the current decreases when less heat isbeing transferred between the surfaces.

The Peltier-effect cooling method uses the two junctions of asemiconductor 530 (FIG. 37) which are heat-transfer activity cells in amanner such that a first junction 531 is in contact with the fluid ortissue adjacent to it which transmits heat energy from the urethra to asecond heat junction 532 within the body 501. This transmitted heat isquickly reabsorbed by the body 501 and surrounding tissue or fluidsurrounding the body 501. Similar to the electrical resistanceembodiment above, a voltage threshold comparator and relay 599 thencompares this current with the predetermined, preset current. When achange in the rate of heat transfer occurs (dQ/dt=change in heatflow/change in time), it provides an electrical indication that theemergence into the bladder neck or bladder from the urethra (orwithdrawal therefrom) has occurred because the thermal conductivitydiffers when the apparatus 500 is in the urethra or is in the bladderneck or bladder. Electrical circuitry controlling the current flowthrough the apparatus 500 then generates an appropriate feedback signalas explained below. The emergence into the bladder neck or bladder,which normally contains some residual of fluid, provides for adifference in heat transfer to or from the urethra.

The semiconductor 530 has a thin construction of an overall dimension ofapproximately 0.008 inch in thickness with width dimensions of 0.020inch and 0.040 inch. On each of the heat transfer surfaces, a gold orplatinum conductive layer is applied using vapor deposition.Alternatively a 0.0008 conductive film may be adhered to the surface 503of the body 501 using conductive epoxy adhesive. The foil assists in thetransfer of heat and provides a noble and biocompatible surface forinterface with the surrounding environment. The dimensions ofsemiconductor 530 determine the ability to transfer heat from the lowertemperature junction to the higher temperature junction. In thisapplication the useful determinate indicator of position is derived fromthe change in power which is used to transfer the heat rather than ameasurement of the heat transfer. The power changes as the surroundingenvironment changes when the first junction 531 of the semiconductor 530enters the bladder neck or bladder from the urethra.

FIGS. 38A is a circuit flow diagram showing the current flows duringcoupling for this embodiment and aids to further explain the embodiment.FIG. 38B is a circuit flow diagram shows the current flows duringpositioning. Low-voltage, direct current flows from a battery 559through a positive lead 584 to the switch 585 and then through a lead568b and is conditioned by a voltage conditioner 580, which provides thedesired voltage and current limits. The current flows then through alead 568Ab, through a contact collar 570 of the insertion tool 550 and acontact collar 516 of the apparatus 500, and through the electrical lead517 to the semiconductor 530. The current passes through thesemiconductor junctions 531 and 532 and is conducted back through theelectrical lead 518, through the contact collars 516 and 570, andthrough the second electrical lead 568a in the insertion tool 550 to thevoltage threshold comparator and relay 599. When the insertion tool 550and apparatus 500 enter the bladder neck or bladder, the change inenvironment causes the first junction 531 to absorb a different amountof heat, thereby causing a resultant change in current. The voltagethreshold comparator and relay 599 then compares this current with thepredetermined, preset current. When the current value exceeds the presetlevel, the voltage threshold comparator and the relay 599 energizes theinput contact 589 through the lead 568e with line voltage from thebattery 559. Depending on the position of the switch 585, either thelight only, or the light and alarm give an indication that the apparatus500 has entered the bladder neck or bladder as previously described inother embodiments.

VI. EMBODIMENTS WITH FIBER OPTIC SENSING:

FIGS. 39 through 45B show alternative embodiments of urethral apparatus600A and 600B that use fiber optics for position sensing. In theseembodiments, the fiber optics are incorporated into the urethralapparatus to initiate a feedback signal that the apparatus is properlypositioned. In this embodiment, the sensing component are showngenerally at 612A and 612B, respectively. The embodiment 600A shown inFIGS. 39 through 44B includes two fiber optic strands that provide forsignal transmission and return. The fiber optic strands are composed ofa central core of diameter of approximately 8 to 10 micron with a totalclad or unclad diameter of approximately 125 micron (or approximately0.005 inch).

Referring to FIGS. 44A and 44B, current flows from a battery 659A to aswitch 685A, then through a lead 668Ab to a voltage conditioner 680A,which provides the correct voltage and current to an LED 696A. Alow-energy light wave preferably in the visible light spectrumwavelengths of 400-750 nanometers is transmitted by a bulb orlight-emitting diode (LED) 696A or bulb into the first insertion toolfiber optic strand 697Aa to the insertion tool contact collar 670A andterminates there within the strand casing at a mating contact point671Aa, which may be a similar glass fused contact mounted within thecontact collar 670A or a dissimilar material that has been bonded aroundthe perimeter, which in turn is bonded into the insertion tool contactcollar 670A.

A first apparatus fiber optic strand 633Aa (FIG. 40) terminates in likemanner at a mating contact point 634Aa of an apparatus first contactcollar 616A and extends within the body 601A to a location at a proximalportion 607A. A second apparatus fiber optic strand 633Ab lies alongsidethe first apparatus fiber optic strand 633Aa and is coupled in likemanner at a mating contact point 634Ab of the apparatus first contactcollar 616A. Facing the terminal ends of the first and second apparatusfiber optic strands 633Aa and 633Ab is a mirror 635A, which reflectslight emitting from the first apparatus fiber optic strand 633Aa intothe second apparatus fiber optic strand 633Ab. Similarly, a secondinsertion tool fiber optic strand 697Ab lies alongside the firstinsertion tool fiber optic strand 697Aa and terminates in a handpiecehousing 651A and contact collar 670A at a mating contact point 671Ab.

An additional feature of this embodiment is the use of a shape-memory,nonreflective member 636A (FIGS. 40 and 41) that is interposed betweenthe terminal ends of the first and second apparatus fiber optic strands633Aa and 633Ab and the mirror 635A during insertion of the coupledinsertion tool 650A and urethral apparatus 600A, thus, effectivelypreventing light from being returned through the second apparatus fiberoptic strand 633Ab. When the portion of the apparatus 600A containingthe nonreflective member 636A enters the bladder neck or bladder, theshape-memory characteristics of the nonreflective member 636A cause itto move outward and therefore allow the light circuit to be completed(FIGS. 42 and 43). The nonreflective member 636A optionally has anadditional leaf 637A to ensure complete blockage of the light circuitbetween the terminal ends of the apparatus fiber optic strands 633Aa and633Ab and the mirror 635A. Alternately, deformation can take place inresponse to internal pressure from self-contained fluid in a reservoiradjacent the nonreflective member 636A. Alternately, the reflective andabsorptive properties of the leaf 637A and the mirror 635A could bereversed in such a manner that the light from the fiber optic strands isreflected by the leaf 637A and the mirror 635 is replaced by anonreflective surface.

As the urethral apparatus 600A enters the bladder neck or bladder, theshape-memory characteristics (or, alternately, fluid pressure) cause thenonreflective member 636A to move outward and thereby allow the lightcircuit to be completed (see FIG. 44b). As the light is returned to thesecond insertion tool optic fiber strand 697Ab and is incident upon theoptical transducer 698A, the light energy is converted into anelectrical signal, which is carried by the lead 668Aa to a voltagethreshold comparator and relay 699A. The voltage threshold comparatorand relay 699A then compares this voltage with the predetermined, presetvoltage. When the voltage value exceeds the preset level, the voltagethreshold comparator and relay 699A energizes an input contact 689Athrough the lead 668Ae with line voltage from the battery 659A.Depending on the position of the switch 685A, either the light only, orthe light and alarm give an indication that the apparatus 600A hasentered the bladder neck or bladder as previously described in otherembodiments.

In an alternative embodiment shown in FIGS. 45A and 45B, the urethralapparatus 600B has only one fiber optic strand 633Ba and has an opticaltransducer 638B located in the distal portion 605B of the body 601B withan electrical lead 618B leading from the optical transducer 638B to aconducting surface 616Bc. Current then flows to a contact 670Bd of theinsertion tool 650B and to a voltage threshold comparator and relay 699Bthrough the lead 668Bd. When the current value exceeds the preset level,the voltage threshold comparator and relay 699B energizes the inputcontact 689B through the lead 668Be with line voltage from the battery659B. Depending on the position of switch 685B, either the light only,or the light and alarm give an indication that the urethral apparatus600B has entered the bladder neck or bladder as previously described inother embodiments.

Optionally, the mirror 635A (or 635B) may be eliminated in either of theconfigurations shown in FIGS. 44A and 44B (or 45A and 45B) by orientingthe two ends of the fiber optic strands 633Aa and 633Ab (or optionally,first fiber optic strand 633Ba and optical transducer 638B) at a spaceddistance across from each other with the non-reflective shape-memorymember 636A (or 636B) interposed between the two elements. Similarcircuitry to that described above would be employed.

In an alternate embodiment using fiber optics, position sensing can bederived from the reflection of light from the urethral surface. Suchreflection is dependent upon the incidence of the surface and thedistance to the surface on which the light is imparted. It is notnecessary to visualize details of the internal surface of the urethra inorder to detect the position of the apparatus within the urethra.Instead, it is important to be able to macroscopically characterize theenvironment and identify when the environment changes from that of theurethral surface to the urine occupying the bladder neck or bladder.

Use of fiber optics to derive position sensing from intraurethralreflection is provided by incorporating one or more fiber optic strandsin two locations along the body of the urethral apparatus or theinsertion tool. A first strand illuminates the area to be evaluated. Thesecond strand conducts a surface illumination from the illuminatedsurface to the insertion tool. Alternately, a first strand illuminatesthe area to be evaluated, and a photovoltaic cell is used to receive theincidence light and generate an electric voltage that produces a currentthat is conducted to the indicator unit. There is much informationavailable from this returned illumination; however, little or nothingmore is needed than the intensity of the returned signal. This outputvoltage may then be used to indicate the change in reflection thatoccurs as the apparatus enters the bladder neck or bladder. This changemay be electronically detected, and the caregiver who is inserting theurethral apparatus is thereby alerted.

VII. ADVANTAGES OF THE DISCLOSED EMBODIMENTS

Advantages of the embodiments disclosed herein include ease of use andlow cost while providing one critical piece of information--properpositioning. These advantages obviate the need for more expensiveequipment or expensive professional medical skills, which wouldotherwise be necessary to obtain information about the relative positionof the urethral apparatus. The disclosed embodiments provide anindication of a change sensed when the sensing component of the urethralapparatus makes the transition from the urethra into the bladder, ormore preferably, the bladder neck. The sensing component preferably isnot used to obtain any specific measurements, such as urethral pressureprofiles and so on. The sensing component responds to a one-time changethat results in a signal being emitted to the person, such as thecaregiver or even the patient. That signal can be audible, visual,tactile, or any other type of signal that informs the caregiver orpatient of the change in the conditions or features surrounding theurethral apparatus as it enters the bladder neck or bladder.

VIII. FURTHER ALTERNATIVE EMBODIMENTS

There are additional alternate embodiments that can be made withoutdeparting from the scope and the spirit of the inventive subject matter.

In some of the embodiments described above that use electrical sensing,the sensing component includes a structure (e.g., 123 in FIG. 5) havingshape-memory characteristics. Such structure can assume any number ofalternate shapes, configurations, or characteristics. For example, thesensing component can be a movable or mechanical structure in the shapeof flexible fingers or wings, or can be an electromechanical structure,a pneumatic or hydraulic member, a light-emitting-and-receiving member,an electronic member, a heat-transfer member, or any other type ofcomponent or structure that detects a change of the component from afirst status to a second status.

It will be appreciated that other mechanisms for sensing a change in theenvironmental conditions, features, or parameters proximate the urethralapparatus when it passes out of the urethra and into the bladder or thebladder neck fall within the scope and spirit of the disclosed inventivesubject matter. The embodiment disclosed herein should not be construedto include all permutations, but instead provide an indication of someof the permutations that are possible. Some of these alternateembodiments are detailed below.

Still other embodiments may incorporate the sensing component as part ofthe insertion tool. Such embodiments may be adapted to any of theinsertion tool embodiments (150, 250, 350, 450, 550, and 650, describedabove). A purpose of the sensing component 112 is to initiate a feedbackchain to indicate the position of the body of the urethral apparatusbased upon a change in an environmental condition, feature, or parameteras the proximal portion (e.g., 107 in FIG. 1) or proximal end (e.g., 108in FIG. 1) of the body of the urethral apparatus passes at leastpartially out of the urethra and into the bladder or bladder neck. Sincethe length of the body 101 of the urethral apparatus may be varied, thesensor component can be part of the insertion tool in some alternativeembodiments. For example, in an embodiment that uses an opticaltransducer for position sensing (e.g., FIGS. 39 through 44B), theoptical transducer may be included in the proximal end of the insertiontool (e.g., 650A) with fiber optics either on the insertion tool itselfor on the body of the urethra apparatus.

Although many of these embodiments teach the placement of the sensingcomponent 112 at or near the proximal end of the body of the urethralapparatus, the sensing component 112 may be located at the distal end ordistal portion and still provide an indication of the proper placementof the urethral apparatus in relation to the bladder neck or bladder.

A. DRUG DELIVERY EMBODIMENTS

Referring to FIGS. 46A and 46B, an embodiment of a urethral apparatus700A is disclosed. The embodiment 700A provides for drug delivery. Forthe sake of clarity in the drawings, the sensing component 712A is notillustrated in FIG. 46A or 46B but is considered to be a part of theembodiment described. The body 701A incorporates one or more fluid ports713A with an optional one-way flow-restrictor valve 715A (FIG. 46b) incommunication with one or more fluid passageways 711 A that pass throughthe body 701 A and that are in communication with corresponding fluidlumens (not shown) in an insertion tool. The insertion tool may besimilar to any of the insertion tool embodiments disclosed above.

In an alternative embodiment of the urethral apparatus 700B shown inFIG. 47, the body 701B incorporates a porous or microporous membrane739B in communication with a fluid lumen 711B (or alternately, areservoir 719B) in the body 701B. The membrane 739B can extend aroundpart or all of the circumference of body 701B. These ports or membranesare used to introduce drugs, agents, genes, monoclonal antibodies, orother materials either passively or actively, for example, usingdiffusion, osmosis, iontophoresis, electrophoresis, photodynamicmethods, pressure, ultrasound, or other driving or activating forces.Those skilled in the art will recognize that some of these drug-deliveryembodiments require the addition of drug reservoirs, electrodes,transducers, or other components necessary to the technology.

In other embodiments the alternate fluid ports or membranes are locatedin a position along the periphery of the body so that drugs or agentsare introduced to the prostate, for example. Similarly, a portion of thealternate body may itself contain drugs or other agents impregnated in apolymer, for example, for a controlled- or time-released therapy. Suchdrugs could, for example, be an antibiotic agent or oligodynamic tal tocounter or modify bacterial growth in the urethra, bladder neck, orbladder.

B. VALVED URETHRAL APPARATUS EMBODIMENT

Referring to FIGS. 48 through 54, there is disclosed another embodimentof a urethral apparatus 800. This embodiment includes a body 801 thatincorporates a valving mechanism, such as a magnetic valve 839. (For thesake of clarity in the drawings, the sensing component is not includedin the drawings but is considered to be a part of the embodimentdescribed. It will be appreciated that any of the embodiments of theurethral apparatus having position sensing can further incorporate avalve in any manner or iteration possible.) This first valvingembodiment uses magnetics and stored energy to control the flow of urineand to dampen pressure impulses arising from momentary, and often sharp,increases in bladder pressure as a result of exercise, coughs, laughing,or other sudden or strenuous responses or reflexes.

FIG. 48 shows the magnetic valve 839 in a closed position. The body 801has an open proximal end 808 that extends into the bladder neck orbladder and comprises a fluid-flow director 837 with a lumen 810. Withinthe lumen 810, a seal 840 is slidable such that it provides for afluid-tight seal to prevent leakage of urine through the body 801 of theurethral apparatus when the valve is in a closed position (see forexample FIG. 48) or dampened position (see for example FIG. 49) butallows fluid to flow through the body 801 in the open position (see forexample FIGS. 50 and 51). Connected distally to the seal 840 is aplunger 841 and a magnet 842. The seal 840, the plunger 841, and themagnet 842 function as a unit to control the flow of urine through thebody 801.

The magnet 842 travels axially in a longitudinal direction within amagnetic profiler 843 which has an enlarged proximal end 844, anenlarged distal end 845, and a stop 846, which serves to limit travel ofthe magnet proximally within the magnetic profiler. As shown in FIGS.48, 52, and 53, the fluid-flow director 837 has one or more openings 847that communicate with passageways 832 to allow urine flow. Openings 847are located distal of the seal 840 when the magnet 842 is positioned ina closed position or is in a damping position. The magnet 842 is shapedto allow urine to flow around its periphery (FIGS. 54A and 54B ) and outthrough the distal end 806 of body 801.

The proximal end 844 and optionally the distal end 845 of the magneticprofiler 843 are made of a material that interacts with the magnet 842to controllably influence the travel of the magnet 842 in a longitudinaldirection. When the magnet 842 is in a closed position (FIG. 48), amagnetic circuit is formed between the magnet 842 and proximal end 844.When bladder pressure is increased above a critical pressure, the forceof urine against the seal 840 causes the magnet 842 to move away fromthe stop 846 in a distal direction. As the magnet 842 moves distallythrough the magnetic profiler 843, magnetic forces may optionally beexerted by the distal end 845 to interact with the magnet 842 and assistin moving the magnet 842 distally. As bladder pressure is increased to agreater degree, the magnet 842 is physically pushed toward the distalend 845. The seal 840 then moves distally beyond the openings 847 andallows urine to flow distally through the body 801 (FIG. 50). As theurine flow is diminished and pressure is decreased on the seal 840, themagnet 842 is drawn proximally toward the stop 846 by the magneticforces existing between the magnet 842 and the proximal end 844. Themagnetic circuit is again completed between the magnet 842 and theproximal end 844 to hold the valve in a closed position. If the distalend 845 is also constructed of a material that interacts magneticallywith the magnet 842, the force of the magnetic flux or circuit betweenthe magnet 842 and the proximal end 844 is greater than the force of themagnetic flux or circuit between the magnet 842 and the distal end 845,thus allowing the magnet 842 to always return to a closed position.Alternately, a member that interacts with the magnet 842 could belocated in a position distal to the distal end 845.

If the user experiences a momentary impulse in bladder pressure due toexercise, coughing, or laughing, for example, the seal 840 experiencesvery high, but very temporal, pressures. The magnetic field formedbetween the magnet 842 and the proximal end 844 absorbs the energyexerted upon them by the controlled displacement of the plunger 841 andthe magnet 842 as the plunger is displaced along the axis of the fluidflow director 837. This displacement provides for energy being stored inthe magnetic circuit, which is subsequently returned in the form of workover time as the plunger is repositioned during the pressure impulse andreturns to a seated, closed position after the impulse. During thisdisplacement, the seal is moved distally but not far enough distally topermit urine flow through the openings 847. Thus, the length of theplunger 841 and the magnetic profiler 843 are such that the maximumimpulse in bladder pressure does not cause the seal 840 to move distallybeyond the openings 847. It is this relationship of work over time thatallows the apparatus to absorb pressure impulses that may be many timesgreater than the pressure needed to actuate the valve using the Credemethod described below.

To actuate the valve, the user or caregiver simply uses the Crede methodby employing his or her hands to exert pressure over the symphysispubis. This increases the pressures within the bladder and initiates thesequence of events that opens the valve.

As a fail-safe feature, the magnetic circuit between the magnet 842 andthe proximal end 844 is over-ridden at a bladder pressure that is lessthan the point at which urine refluxes into the kidneys. Alternately,the apparatus 800 can be actuated by inserting a magnet into the urethrawith enough force to overcome the force of the magnetic circuit formedbetween the magnet 842 and the proximal end 844.

C. ANCHORING

After positioning, any of the embodiments of the urethral apparatus canbe anchored or secured in the urethra, bladder neck, or bladder. Thismay be facilitated by purposefully selecting the diameter, size, shape,and other characteristics of the body of the urethral apparatus based onphysical characteristics of the urethra, bladder neck, or bladder.

First, anchoring of any of these embodiments may be accomplished by thephysical compression of the urethral wall against the body of theurethral apparatus. This is the result of the circumferential pressureinstilled upon the body by the urethra. These distributed forces shouldbe sufficient to provide for a longitudinal restriction of movement thatexceeds the maximum force instilled upon the projected area of the bodyby the hydraulic pressure of the urine.

Second, anchoring may also be facilitated by selecting a urethralapparatus body with a cross-sectional area that is appropriate for theindividual user. In some embodiments, the projection of the surface areacombined with the longitudinal surface area, shape, and texture may besufficient for mechanical anchoring to offset incident hydraulic orphysiologic forces that would otherwise shift or expel the urethralapparatus. Designing the longitudinal axis surface to be cylindrical,ellipsoidal, hyperbolic, sinusoidal, helical, or wedge-shaped, or tohave various cross-sectional areas or circumferences along thelongitudinal axis (including barb-like projections) is effective inacquiring sufficient anchoring.

Third, anchoring can also be accomplished by the addition of variousexternal features to the exterior of the body or modifications in thematerial characteristics that comprise the body or exterior. Theseinclude, but are not limited to, features such as flexible fingers orwings that unfold in the bladder, variation of surface texture andasperity heights, surface compressibility, length, contour, protrusions,grooves, axial stiffness, geometric patterns, tissue entrapment surfacessuch as recesses or pressure points, material frictionalcharacteristics, material uniformity (or alternately non-uniformity),regional rigidity, projected area, and other characteristics. Thecombination of the urethral system dynamics and of the surfacecharacteristics of the apparatus while in contact with the urethral wallultimately determine the adequacy of the anchoring of the body of theurethra apparatus. In order for the various embodiments to be effective,controllable anchoring is desirable, if not mandatory, and dependablypredictable once the user's urethral environment has been clinicallycharacterized. Any of these anchoring techniques can be enhanced by theuse of adhesives. In addition, the proximal and distal ends of the bodymay have radiused, atraumatic edges.

An embodiment having an anchoring structure is disclosed in FIGS. 55 and56. A urethral apparatus 900 includes a sinusoidal surface 910a along anexternal surface 903 of the body 901. External surface 903 has lowersurface portions 930a and higher surface portions 932a. These highersurface portions 932a may have varying degrees of compression, rangingfrom slightly compressible to very compressible. The offset sinusoidalsurface 910b (FIG. 56) may also aid in insertion of the urethralapparatus, since during insertion, the insertion tool and the urethralapparatus are coupled together in a locked position and are capable ofbeing rotated as a unit. The offset sinusoidal surface 910b also haslower surface portions 930b and higher surface portions 932b.

FIG. 57 shows the incident forces and hydraulic urine pressures exertedon the body 901. Pressure is incident upon the projected area 941, whichis exposed to urine at the bladder neck 42. The urethra 40 contacts theexternal surface 903 of body 901 along its length. This pressure is afunction of length P(L), and circumference is a function of length C(L);either may be variable along the length. (The nomenclature dL indicatesan infinitesimal change in length as used in integration.) FIG. 57illustrates that each variable contributes to anchoring the urethralapparatus 900 within the urethra.

Anchoring is accomplished by the summation of all the forces between thebody 901 and the urethra 40 exceeds the maximum peak forces exerted overtime by fluid pressures that contact the projected area 941 of thesurface. The forces imparted on body 901 are hydraulic and physiological(e.g., spasm). Hydraulic forces may be high pressure, short-durationimpulses caused by laughing or coughing or other sudden stresses on thebladder. The body 901 remains stable when the smaller, hydraulic forcesresulting from the urine are imparted on the urethral apparatus overlong periods of time. These prolonged hydraulic forces may occur in theuse of urethral apparatus 900 with a urine-control feature as in theembodiment of the magnetic valve (FIG. 48) at the time just prior tourine release.

Embodiments of the urethral apparatus body with internalflow-restriction components may be retained in the urethra at thebladder neck or bladder when impulses of pressure peaks upon it rangefrom 4 to 268 inches of water for a time duration of up to 3 seconds, orwhen the urethral apparatus is subjected to prolonged pressurizationranging from 1 to 60 inches of water for up to 8 hours withoutdisplacement. The embodiment of the urethral apparatus body 901 with thehigher surface 932a as shown in FIG. 55 can be used with changes inamplitudes ranging from approximately 1 percent to approximately 400percent of the area as measured to the lower surface 930a. The higheramplitudes and variation of surfaces are useful for greater anchoringrequirements.

Another alternative structure for anchoring or retaining the urethralapparatus is illustrated in FIGS. 58A-58C and FIGS. 59A-59E. FIGS.58A-58C illustrate a female version of a urethral apparatus 1000A, andFIG. 59A-59E illustrate a longer, male version 1000B. These embodimentsof urethral apparatuses includes external protrusions or anchors 1045Aor 1045B. As illustrated, these protrusions 1045A or 1045B may becomplete helical ribs or partial helical ribs. These embodiments alsoinclude one or more complete circumferential sealer rings 1029A, 1029Blocated adjacent to or intermixed with these anchors 1045A or 1045B,respectively. The addition of sealer rings 1029A, 1029B aid inpreventing urine leakage between the urethral apparatus body 1001 andthe urethra. These anchors 1045A, 1045B or sealer rings 1029A, 1029B canvary in height, length, number, compressiveness, axial placement,material characteristics, and helix angle varying from 0 to 300 degrees,and more preferably from 15 to 300 degrees. The maximum amplitude ofeach anchor may extend along the entire length of a middle portion ofthe anchor, or may extend along only part of the middle portion of theanchor. These anchors 1045A, 1045B or sealer rings 1029A, 1029B do notinterfere with any of the various sensing components described in thealternate embodiments above. Most of the sensing components arepreferably located in a proximal portion 1007A (see FIG. 58A), althoughin alternative embodiments the sensing components may be located in amiddle 1040A or distal portion 1005A as well.

Anchor features are cast onto the outer circumference of the tubularbody 1001A, 1001B using a Shore A 30 Durometer silicone rubber compound.The specific compounds used for casting the anchoring and sealingfeatures are RTV 430 silicone rubber resin and Beta 11-D1 siliconecatalyst solution, both manufactured by GE Silicones of Waterford, N.Y.

Certain advantages can be gained by using partial helical anchors 1045A,1045B (as shown in FIG. 58B and 58C) arranged in such a manner so thatas the urethral apparatus is rotated through the urethra, each helicalanchor does not come into contact with the urethral surface contacted bythe proximally adjacent anchor, thereby eliminating trauma to theurethra while still providing for anchoring and easy insertion.

Any of the above described embodiments are compatible with theimplementation of valves or other therapeutic, diagnostic, orurine-control elements. Embodiments without internal urine-flowrestrictions, such as for the implementation of a stent or fluidconduit, allow urine flow freely with only a minimal pressure due to thesmall projected area as explained previously and illustrated in FIG. 57.In embodiments with relatively unrestricted fluid flow, the extent ofsurface contact (or total force) required for anchoring is substantiallyless than in embodiments with more restricted fluid flow. Thus, thesurface and size modifications of urethral apparatus body can bepurposefully made to make it easily insertable and retainable.

Further disclosure regarding anchoring is included in U.S. applicationSer. No. 08/914,487 filed Aug. 19, 1997.

It is to be understood, however, the even though numerouscharacteristics and advantages of the present invention have been setforth in the foregoing description, together with details of thestructure and function of present invention, the sequence or order ofthe specific steps, or the actual compositions, environmentalconditions, and the like experienced or sensed may vary somewhat.Furthermore, it will be appreciated that this disclosure is illustrativeonly and that changes may be made in detail, especially in matters ofshape, size, arrangement of parts, or sequence of elements of thevarious aspects of the invention within the principles of the inventionto the full extent indicated by the broad general meaning of the termsin which the appended claims are expressed.

I claim:
 1. A method of positioning a tubular body of a urethralapparatus having a sensor located on the urethral apparatus in a urethracomprising the steps of:inserting a proximal end of the tubular body ofthe urethral apparatus having a sensor located on the urethral apparatusin the urethra; manually moving the urethral apparatus proximally towardthe bladder; receiving an indication from the sensor located on theurethral apparatus that the proximal end of the urethral apparatus is atthe bladder; and ceasing movement upon receiving the indication from theurethral apparatus that the proximal end is at the bladder.
 2. Themethod of claim 1 wherein said indication causes an audible signal tosound.
 3. The method of claim 1 wherein said indication causes avisually observable signal.
 4. The method of claim 1 further comprisingthe step of:coupling a distal end of the tubular body of the urethralapparatus having a sensor to a proximal end of an insertion tool priorto the step of manually moving the urethral apparatus proximally towardthe bladder.
 5. The method of claim 4 further comprising the stepof:decoupling the insertion tool from the urethral apparatus having asensor after the step of ceasing movement thereby leaving the urethralapparatus in place in the urethra.
 6. The method of claim 4 wherein saidindication is transmitted through the insertion tool.
 7. The method ofclaim 5 comprising the steps of:after the step of decoupling, removing,removing the insertion tool from the urethra; and after a period oftime, removing the urethral apparatus by advancing the proximal end ofthe insertion tool into the urethra, coupling the distal end of thetubular body of the urethral apparatus with the proximal end of theinsertion tool, and withdrawing the coupled insertion tool and urethralapparatus from the urethra.
 8. The method of claim 4 further comprisingthe step of:after the step of coupling the insertion tool to the tubularbody, receiving a signal from the insertion tool that the insertion tooland urethral apparatus are coupled together.
 9. A method of positioninga urethral apparatus having a sensing component located on the urethralapparatus comprising:coupling a distal end of the urethral apparatushaving a sensing component located on the urethral apparatus to aproximal end of an insertion tool; advancing the coupled urethralapparatus and insertion tool proximally through the urethra toward thebladder; sensing a change in a feature of the urethra with the sensingcomponent located on the urethral apparatus; transmitting a signal inresponse to said sensed change from the urethral apparatus to saidinsertion tool; and providing a signal from the insertion tool that theproximal end of the urethral apparatus is properly positioned relativeto the bladder neck and bladder.